Primary SpondylodiscitisNCT07509983
One Year Results of Managing Primary Spondylodiscitis
An observational study of Primary Spondylodiscitis and Pyogenic Spondylodiscitis, run by Assiut University.
Trial summary
Primary spondylodiscitis is a severe infectious condition involving the spinal discs and adjacent vertebrae. It often causes significant back pain and requires careful management, typically involving long-term antibiotics and spinal braces, or surgery in more complex cases. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Primary Spondylodiscitis, Pyogenic Spondylodiscitis, Spinal Infection
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- May 2026to Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population comprises patients of any age or sex presenting to the Orthopedic and Trauma Surgery Department (encompassing both inpatient wards and outpatient clinics) at Assiut University Hospital with clinical symptoms and/or radiological findings suggestive of primary pyogenic (bacterial) spondylodiscitis.
Who may be able to join
- All patients presenting to Assiut University Hospital and its affiliated outpatient clinics with clinical symptoms and/or radiological findings suggestive of primary pyogenic (bacterial) spondylodiscitis, regardless of age or sex.
Who cannot join
- Patients with postoperative or iatrogenic spinal infections (secondary spondylodiscitis following spinal surgery or instrumentation).
- Non-pyogenic spondylodiscitis.
- Patients with incomplete medical records or insufficient follow-up data.
- Patients who decline to provide informed consent.
About this study
Official title: One Year Results of Managing Primary Spondylodiscitis in a Tertiary Care Center
Primary spondylodiscitis is a severe infectious condition involving the spinal discs and adjacent vertebrae. It often causes significant back pain and requires careful management, typically involving long-term antibiotics and spinal braces, or surgery in more complex cases. The purpose of this observational study is to evaluate the one-year clinical and surgical outcomes of patients receiving standard-of-care treatment for primary spondylodiscitis at Assiut University Hospital.
The study aims to enroll approximately 50 patients. Researchers will follow these participants prospectively for one year from the start of their treatment. During this time, patients will undergo regular clinical evaluations, laboratory blood tests (such as CRP and ESR to monitor infection and inflammation), and radiological imaging (like X-rays) at defined intervals to assess healing and spinal stability.
The primary objective is to determine the overall cure rate at the one-year mark. Additionally, the study will measure secondary outcomes, including changes in pain levels, improvements in daily functional abilities, and the rate of any complications or necessary surgical interventions.
Read the detailed description
Primary spondylodiscitis represents a significant diagnostic and therapeutic challenge, with its incidence rising due to an aging population and increasing prevalence of comorbidities. This prospective exploratory clinical follow-up study aims to establish systematic data collection using REDCap to evaluate the clinical and surgical outcomes of patients managed for primary spondylodiscitis at Assiut University Hospital.
Upon enrollment, all patients will undergo a comprehensive baseline assessment. This includes a structured medical history focusing on comorbidities (such as diabetes, malignancy, or immunocompromised states) and specific symptomatology. A thorough physical and neurological examination will be performed to assess spinal tenderness, range of motion, motor power, sensory levels, and sphincter function. Baseline laboratory investigations will include complete blood count (CBC), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and aerobic/anaerobic blood cultures. Radiological assessment will proceed sequentially with plain radiographs, magnetic resonance imaging (MRI) with contrast, and computed tomography (CT) as needed. If blood cultures are negative or an epidural abscess is present, a percutaneous biopsy will be performed.
Patients will be managed according to standard institutional protocols, which include:
- Antibiotic Therapy: Intravenous empirical therapy (e.g., vancomycin combined with a broad-spectrum beta-lactam) will be initiated and later targeted based on culture results. Parenteral antibiotics will be administered for a minimum of 6 weeks. Transition to oral antibiotics will occur once clinical improvement and a ≥50% reduction in CRP are documented, for a total minimum treatment duration of 8 to 12 weeks.
- Spinal Immobilization: Conservatively managed patients will be fitted with a spinal orthosis to minimize mechanical stress and prevent deformity, maintained for a minimum of 10 weeks.
- Surgical Intervention: Surgery will be indicated for patients presenting with progressive neurological deficits, spinal instability, large/inaccessible abscesses, or failure to respond to at least 6 weeks of adequate antimicrobial therapy. Intraoperative tissue biopsies will be sent for microbiological and histopathological examination.
Patients will be followed prospectively for one year from the initiation of treatment.
- Clinical Monitoring: Pain and functional outcomes will be evaluated using the Visual Analogue Scale (VAS), AO Spine PROST, EQ-5D, SITE Score, and SISS Score at predetermined intervals: baseline, 6 weeks, and at 3, 6, 9 (for specific scores), and 12 months.
- Laboratory Monitoring: CRP and ESR will be measured at baseline, at 6 weeks post-treatment, and then every 2 months until normalization. A target CRP of <5 mg/L on two consecutive measurements serves as the biochemical cure benchmark.
- Radiological Monitoring: Plain X-rays will be obtained at 3, 6, and 12 months to evaluate spinal alignment, stability, and bony fusion. Advanced imaging (CT or MRI) will only be repeated in cases of clinical deterioration, worsening pain, or new neurological deficits to detect complications or recurrence.
- Keywords
- Primary Spondylodiscitis, Pyogenic Spondylodiscitis, Spinal Infection, Conservative Management, Surgical Intervention, Tertiary Care, Epidural Abscess, Orthopedic Surgery
- Medical subject headings
- Epidural Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Primary Pyogenic Spondylodiscitis Cohort | A single cohort consisting of all eligible patients presenting with clinical symptoms and/or radiological findings suggestive of primary pyogenic (bacterial) spondylodiscitis. Participants will be managed according to the current standard of care treatment protocols, which involve either conservative management or surgical intervention. Conservative management includes prolonged empirical or targeted antibiotic therapy for a minimum of 8-12 weeks combined with spinal immobilization using an orthosis for at least 10 weeks . Surgical intervention is indicated for patients with progressive neurological deficits, spinal instability, large abscesses, or failure to respond to conservative medical management. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients Achieving Definitive Cure
This outcome measures the overall cure rate among participants. A definitive cure is successfully achieved if the patient survives without documented disease recurrence, does not require additional unplanned antibiotic courses or reoperation, and shows radiological confirmation of infection eradication with restored or maintained spinal stability.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study startMay 2026 (estimated)
- Primary completionMay 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary SpondylodiscitisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Nabil, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07509983
- Sponsor's protocol ID
- Managing of Spondylodiscitis
- Status last verified
- Mar 2026
- First submitted
- 28 Mar 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One Year Results of Managing Primary Spondylodiscitis in a Tertiary Care Center
- ClinicalTrials.gov ID
- NCT07509983
- Acronym / sponsor ID
- Managing of Spondylodiscitis
- Keywords
- Primary Spondylodiscitis, Pyogenic Spondylodiscitis, Spinal Infection, Conservative Management, Surgical Intervention, Tertiary Care, Epidural Abscess, Orthopedic Surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- May 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 3 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary spondylodiscitis is a severe infectious condition involving the spinal discs and adjacent vertebrae. It often causes significant back pain and requires careful management, typically involving long-term antibiotics and spinal braces, or surgery in more complex cases. The purpose of this observational study is to evaluate the one-year clinical and surgical outcomes of patients receiving standard-of-care treatment for primary spondylodiscitis at Assiut University Hospital.
The study aims to enroll approximately 50 patients. Researchers will follow these participants prospectively for one year from the start of their treatment. During this time, patients will undergo regular clinical evaluations, laboratory blood tests (such as CRP and ESR to monitor infection and inflammation), and radiological imaging (like X-rays) at defined intervals to assess healing and spinal stability.
The primary objective is to determine the overall cure rate at the one-year mark. Additionally, the study will measure secondary outcomes, including changes in pain levels, improvements in daily functional abilities, and the rate of any complications or necessary surgical interventions.
Detailed description
Primary spondylodiscitis represents a significant diagnostic and therapeutic challenge, with its incidence rising due to an aging population and increasing prevalence of comorbidities. This prospective exploratory clinical follow-up study aims to establish systematic data collection using REDCap to evaluate the clinical and surgical outcomes of patients managed for primary spondylodiscitis at Assiut University Hospital.
Upon enrollment, all patients will undergo a comprehensive baseline assessment. This includes a structured medical history focusing on comorbidities (such as diabetes, malignancy, or immunocompromised states) and specific symptomatology. A thorough physical and neurological examination will be performed to assess spinal tenderness, range of motion, motor power, sensory levels, and sphincter function. Baseline laboratory investigations will include complete blood count (CBC), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and aerobic/anaerobic blood cultures. Radiological assessment will proceed sequentially with plain radiographs, magnetic resonance imaging (MRI) with contrast, and computed tomography (CT) as needed. If blood cultures are negative or an epidural abscess is present, a percutaneous biopsy will be performed.
Patients will be managed according to standard institutional protocols, which include:
- Antibiotic Therapy: Intravenous empirical therapy (e.g., vancomycin combined with a broad-spectrum beta-lactam) will be initiated and later targeted based on culture results. Parenteral antibiotics will be administered for a minimum of 6 weeks. Transition to oral antibiotics will occur once clinical improvement and a ≥50% reduction in CRP are documented, for a total minimum treatment duration of 8 to 12 weeks.
- Spinal Immobilization: Conservatively managed patients will be fitted with a spinal orthosis to minimize mechanical stress and prevent deformity, maintained for a minimum of 10 weeks.
- Surgical Intervention: Surgery will be indicated for patients presenting with progressive neurological deficits, spinal instability, large/inaccessible abscesses, or failure to respond to at least 6 weeks of adequate antimicrobial therapy. Intraoperative tissue biopsies will be sent for microbiological and histopathological examination.
Patients will be followed prospectively for one year from the initiation of treatment.
- Clinical Monitoring: Pain and functional outcomes will be evaluated using the Visual Analogue Scale (VAS), AO Spine PROST, EQ-5D, SITE Score, and SISS Score at predetermined intervals: baseline, 6 weeks, and at 3, 6, 9 (for specific scores), and 12 months.
- Laboratory Monitoring: CRP and ESR will be measured at baseline, at 6 weeks post-treatment, and then every 2 months until normalization. A target CRP of <5 mg/L on two consecutive measurements serves as the biochemical cure benchmark.
- Radiological Monitoring: Plain X-rays will be obtained at 3, 6, and 12 months to evaluate spinal alignment, stability, and bony fusion. Advanced imaging (CT or MRI) will only be repeated in cases of clinical deterioration, worsening pain, or new neurological deficits to detect complications or recurrence.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary Pyogenic Spondylodiscitis Cohort | – | –A single cohort consisting of all eligible patients presenting with clinical symptoms and/or radiological findings suggestive of primary pyogenic (bacterial) spondylodiscitis. Participants will be managed according to the current standard of care treatment protocols, which involve either conservative management or surgical intervention. Conservative management includes prolonged empirical or targeted antibiotic therapy for a minimum of 8-12 weeks combined with spinal immobilization using an orthosis for at least 10 weeks . Surgical intervention is indicated for patients with progressive neurological deficits, spinal instability, large abscesses, or failure to respond to conservative medical management. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population comprises patients of any age or sex presenting to the Orthopedic and Trauma Surgery Department (encompassing both inpatient wards and outpatient clinics) at Assiut University Hospital with clinical symptoms and/or radiological findings suggestive of primary pyogenic (bacterial) spondylodiscitis.
Key inclusion criteria (1 listed)
- All patients presenting to Assiut University Hospital and its affiliated outpatient clinics with clinical symptoms and/or radiological findings suggestive of primary pyogenic (bacterial) spondylodiscitis, regardless of age or sex.
Key exclusion criteria (4 listed)
- Patients with postoperative or iatrogenic spinal infections (secondary spondylodiscitis following spinal surgery or instrumentation).
- Non-pyogenic spondylodiscitis.
- Patients with incomplete medical records or insufficient follow-up data.
- Patients who decline to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Patients Achieving Definitive Cure
Time frame: 1 year
This outcome measures the overall cure rate among participants. A definitive cure is successfully achieved if the patient survives without documented disease recurrence, does not require additional unplanned antibiotic courses or reoperation, and shows radiological confirmation of infection eradication with restored or maintained spinal stability.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Spondylodiscitis and Pyogenic Spondylodiscitis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients Achieving Definitive Cure (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.